Medical dressing having a timer

ABSTRACT

A medical dressing is disclosed herein. The medical dressing, in an embodiment, includes a body and a see-through surface supported by the body. The medical dressing also includes a timer coupled to the body. The timer includes a structure configured to track the passage of time based on liquid diffusion or otherwise without relying on a battery or electrical power source.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of, and claims the benefit andpriority of, U.S. patent application Ser. No. 15/405,720 filed on Jan.13, 2017, which is a non-provisional of, and claims the benefit andpriority of, U.S. Provisional Patent Application No. 62/279,247 filed onJan. 15, 2016. The entire contents of such applications are herebyincorporated by reference.

BACKGROUND

According to standards of care in the healthcare industry, certainmedical articles are to be placed in use for no more than a designatedusage period. For example, in-dwelling catheters are supposed to beremoved and replaced periodically to avoid infection. The Foley urinarycatheter, for example, is supposed to be replaced a designated number ofdays after placement. Other types of medical articles, such as breathingtubes, feeding bags and blood transfusion filters, have other designatedusage periods.

The failure to replace a medical article when its usage period expires,poses significant health risks for the patient. Specifically, thisfailure can cause hospital-acquired infections (HAIs). In the case ofurinary applications, this failure can cause urinary tract infection(UTI) or catheter-associated urinary tract infection (CAUTI). UTI is thesingle most common HAI, and the majority of cases of hospital-acquiredUTI are associated with an indwelling urinary catheter. The consequencesof these infections can include prolonged illness, the onset of newmedical conditions, injury or death.

Attempts have been made to properly manage the usage periods of deployedmedical articles. For example, clinicians are known to attach tags tomedical articles and write dates and times on the tags. Other knownattempts involve timers that are attachable to medical articles.

These attempts, however, have several shortcomings. Hospitals can behigh-paced environments, especially in the areas relating to surgery,including the pre-operative, perioperative and post-operative phases. Itcan be burdensome to require clinicians to physically write times ontags. Also, hand writing can be illegible, leading to inaccurate timetracking information.

Furthermore, use of the known tag and timer can be relatively complex.For example, the use of the known tag and timer requires severalimplementation steps. The clinician must attach the tag or timer to themedical article. Then, the clinician must manually write the time on thetag. When every second is a precious commodity in high-paced medicalenvironments, the burden of these tasks can have a significantdisadvantage, requiring too much time to implement the tag or timer.

In addition, the time pressures on clinicians can lead some of them tointentionally tamper with the known tag or timer. For example, to avoidthe time necessary to replace a medical article, a clinician mightwrongfully mark-out or change the time information written on the knowntag to make it appear as if the usage period has not expired. Likewise,when the timer of a medical article shows an expired usage period, abusy clinician might wrongfully keep the medical article in use whilereplacing its timer with a new timer. The new timer would falselyindicate an unexpired usage period for the medical article. This type oftampering or wrongdoing can lead to the health risks and infectionsdescribed above. The tamper vulnerability and complexities of the knowntag and timer can frustrate the adoption and implementation oftime-tracking practices by the medical community.

The foregoing background describes some, but not necessarily all, of theproblems, disadvantages and shortcomings related to the known managementof usage periods of medical articles.

SUMMARY

In an embodiment, a medical timing device includes: (a) a body includinga first lock member, wherein the body defines an article-receiving spaceconfigured to receive an article portion of a medical article; (b) atimer coupled to the body, wherein the timer is configured to indicatean in-use time of the medical article; (c) a triggering element; and (d)a retainer coupled to the triggering element. The retainer is moveablycoupled to the body, and the retainer is configured to be moved from anopen position providing access to the article-receiving space to aclosed position blocking at least part of the article-receiving space.The retainer includes second lock member, and the retainer is configuredso that, in response to a single action of moving the retainer from theopen position to the closed position: (i) the triggering elementactivates the timer to initiate a process to indicate the in-use time ofthe medical article; and (ii) the triggering element causes the secondlock member to become locked together with the first lock member to lockthe retainer in the closed position after the article portion has beeninserted in the article-receiving space. The locked retainer isconfigured to keep the medical timing device coupled to the articleportion even after the timer may indicate that the medical article hasbeen used for more than a designated usage period. This inhibits thewrongful removal of the medical timing device from the article portion.

In another embodiment, the medical timing device including: (a) a body;(b) a timer coupled to the body, wherein the timer is configured to beactivated so as to indicate in-use time of a medical article; (c) aretainer moveably coupled to the body; (d) a lock condition in which theretainer is moved relative to the body so as to lock the body to anarticle portion of the medical article; (e) an activation condition inwhich the timer is activated; and (f) a multi-condition trigger coupledto the body. In response to a single action applied to themulti-condition trigger, the multi-condition trigger is configured tocause both the lock condition and the activation condition to occursimultaneously or sequentially.

Yet another embodiment includes a method to facilitate monitoring anin-use time of a medical article. The method includes the followingsteps: (a) providing a body; (b) providing a timer, wherein the timer isconfigured to be activated so as to indicate in-use time of a medicalarticle; (c) coupling the timer to the body; (d) providing a retainer;and (e) moveably coupling the retainer to the body, wherein the retaineris moveable relative to the body so as to lock the body to an articleportion of the medical article. The retainer is configured so that, inresponse to a single action that moves the retainer relative to thebody, the timer is activated and the article portion is locked to thebody. The timer activation and locking can occur simultaneously orsequentially.

Additional features and advantages of the present disclosure aredescribed in, and will be apparent from, the following Brief Descriptionof the Drawings and Detailed Description.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side diagrammatic view of an embodiment of a medical timingdevice, an embodiment of a medical device and an embodiment of acatheter securement device, illustrating the open or unlocked position.

FIG. 2 is a side diagrammatic view of the medical timing device, medicaldevice and catheter securement device of FIG. 1, illustrating the closedor locked position.

FIG. 3 is a top, front isometric view of an embodiment of a cathetersecurement device locked onto a urinary catheter, illustrated in theclosed or locked position.

FIG. 4 is a top, rear isometric view of the catheter securement deviceof FIG. 3 locked onto the urinary catheter, illustrated in the closed orlocked position.

FIG. 5 is a top, side isometric view of the catheter securement deviceof FIG. 3 locked onto the urinary catheter, illustrated in the closed orlocked position.

FIG. 6 is a top, front isometric view of the catheter securement deviceof FIG. 3 holding the urinary catheter, illustrated in the open orunlocked position.

FIG. 7 is an enlarged, top, rear isometric view of the cathetersecurement device of FIG. 3 locked onto the urinary catheter,illustrated in the closed or locked position.

FIG. 8 is a top, rear isometric view of the catheter securement deviceof FIG. 3 locked onto a urinary catheter having differently-shapedbranches, illustrated in the closed or locked position.

FIG. 9 is an enlarged, top, side isometric view of the cathetersecurement device of FIG. 3 locked onto the urinary catheter of FIG. 8,illustrated in the closed or locked position.

FIG. 10 is an isometric view of the catheter securement device of FIG. 3locked onto a urinary catheter, illustrating the attachment of thecatheter securement device (in its locked position) to the thigh of aleg of a patient.

FIG. 11 is an isometric view of the urinary catheter of FIG. 8.

FIG. 12 is an enlarged isometric view of the catheter securement deviceof FIG. 3, illustrated in the closed or locked position.

FIG. 13 is an enlarged isometric view of the catheter securement deviceof FIG. 3, illustrated in the open or unlocked position.

FIG. 14 is an enlarged isometric view of the catheter securement deviceof FIG. 3, illustrated in the open or unlocked position, revealing thebranches of the urinary catheter positioned within the cathetersecurement device.

FIG. 15 is an exploded, top isometric view of the catheter securementdevice of FIG. 3.

FIG. 16 is an exploded, bottom isometric view of the catheter securementdevice of FIG. 3.

FIG. 17 is an exploded isometric view of the catheter securement deviceof FIG. 3, illustrating an enlarged view of portions of embodiments ofthe body and retainer.

FIG. 18 is a top isometric view of an embodiment of the security coverof the catheter securement device of FIG. 3.

FIG. 19 is another top isometric view of an embodiment of the securitycover of the catheter securement device of FIG. 3.

FIG. 20 is a bottom isometric view of an embodiment of the securitycover of the catheter securement device of FIG. 3.

FIG. 21 is a bottom isometric view of an embodiment of the timer of thecatheter securement device of FIG. 3.

FIG. 22 is a bottom isometric view of an embodiment of the retainer ofthe catheter securement device of FIG. 3.

FIG. 23 is a top isometric view of an embodiment of the retainer of thecatheter securement device of FIG. 3.

FIG. 24 is a top isometric view of an embodiment of the upper bodyportion of the catheter securement device of FIG. 3.

FIG. 25 is a side isometric view of an embodiment of the upper bodyportion of the catheter securement device of FIG. 3.

FIG. 26 is another top isometric view of an embodiment of the upper bodyportion of the catheter securement device of FIG. 3.

FIG. 27 is a bottom isometric view of an embodiment of the upper bodyportion of the catheter securement device of FIG. 3.

FIG. 28 is another exploded isometric view of embodiments of the upperbody portion, lower body portion and other components of the cathetersecurement device of FIG. 3.

FIG. 29 is yet another exploded isometric view of embodiments of thelower body portion and rotary mount or pivot mount of the cathetersecurement device of FIG. 3.

FIG. 30 is a top isometric view of an embodiment of the rotary mount orpivot mount of the catheter securement device of FIG. 3.

FIG. 31 is a bottom isometric view of an embodiment of the rotary mountor pivot mount of the catheter securement device of FIG. 3.

FIG. 32 is an isometric view of another embodiment of a cathetersecurement device locked onto a urinary catheter, illustrating thecatheter securement device attached to the thigh of a patient.

FIG. 33 is an isometric view of the catheter securement device of FIG.32 locked onto a urinary catheter, illustrating the catheter securementdevice coupled or mounted to a strap.

FIG. 34 is an isometric view of the catheter securement device and strapof FIG. 33, illustrating the strap secured to a patient's thigh.

FIG. 35 is a top isometric view of the catheter securement device ofFIG. 32, illustrating the catheter securement device in the open orunlocked position.

FIG. 36 is a top isometric view of the catheter securement device ofFIG. 32 locked onto a urinary catheter, illustrating the cathetersecurement device in the closed or locked position.

FIG. 37 is a bottom view of the catheter securement device of FIG. 32.

FIG. 38 is a top view of the catheter securement device of FIG. 32.

FIG. 39 is an exploded view of the catheter securement device of FIG.32.

FIG. 40 is a side view of the catheter securement device of FIG. 32,illustrating the catheter securement device in the open or unlockedposition.

FIG. 41 is an isometric view of the catheter securement device of FIG.32, illustrating the catheter securement device in the open or unlockedposition.

FIG. 42 is a cross-sectional view of the catheter securement device ofFIG. 32, taken substantially along line 42-42 of FIG. 36, illustratingthe catheter securement device in the closed or locked position.

FIG. 43 is a top view of an embodiment of a catheter insertion cover.

FIG. 44 is a bottom view of the catheter insertion cover of FIG. 43.

FIG. 45 is an isometric view of the catheter insertion cover of FIG. 43covering the part of a venous catheter entering the skin of a patient.

FIG. 46 is an enlarged, isometric view of the catheter insertion coverof FIG. 43.

FIG. 47 is a front view of yet another embodiment of a medical timingdevice, illustrated locked onto an IV tube which, in turn, is connectedto an IV bag.

FIG. 48 is a top isometric view of the medical timing device of claim47, illustrated in the closed or locked position.

FIG. 49 is a top isometric view of the medical timing device of claim47, illustrated in the open or unlocked position.

FIG. 50 is a cross-sectional view of the medical timing device of claim47, taken substantially along line 50-50 of FIG. 48, illustrating themedical timing device in the closed or locked position.

FIG. 51 is an isometric view of a further embodiment of a medical timingdevice locked onto a ventilation tube, illustrating the medical timingdevice in the closed or locked position.

FIG. 52 is an enlarged isometric view of the medical timing device ofFIG. 51 locked onto the ventilation tube, illustrating the medicaltiming device in the closed or locked position.

FIG. 53 is an enlarged isometric view of the medical timing device ofFIG. 51, illustrating the medical timing device in the open or unlockedposition.

FIG. 54 is an enlarged side view of the medical timing device of FIG.51, illustrating the medical timing device in the closed or lockedposition.

FIG. 55 is an enlarged isometric view of the medical timing device ofFIG. 51, illustrating the medical timing device in the closed or lockedposition.

DETAILED DESCRIPTION

The present disclosure relates to multiple embodiments of a medicaltiming device configured to be secured to a medical article, including,but not limited to, a catheter (e.g., a Foley urinary catheter, venouscatheter or arterial catheter), feeding tube, breathing tube, corrugatedventilation tube, endotracheal tube, tracheostomy tube, ventilationcircuit, catheter insertion dressing, feeding bag component of medicalequipment (e.g., ventilator or respirator), such as a blood transfusionfilter of a blood transfusion machine, and other types of medicalarticles.

In addition, the present disclosure relates to multiple embodiments ofvarious medical devices that incorporate the medical timing device. Forexample, as described below, a catheter securement device canincorporate the medical timing device. Such catheter securement deviceis operable to anchor the catheter to the patient's skin while alsotracking and indicating the usage period of the catheter.

In an embodiment illustrated in FIGS. 1-2, the medical timing device 10includes: (a) a body 14; (b) a retainer 18 moveably or pivotally coupledto the body 14; (c) a timer 22 supported by or coupled to the body 14;(d) a triggering element 26 supported by or coupled to the body 14; and(e) one or more locking members 30, 34 supported by or coupled to thebody 14. In the example shown, the timer 22 is connected to the retainer18. In other embodiments, however, the timer 22 can be connected to thebody 14. Also, in the example shown, upper locking member 30 isconnected to the retainer 18, and lower locking member 34 is connectedto the body 14. In other embodiments, however, the medical timing device10 can include a single locking member 30 or 34 connected to theretainer 18 or the body 14. For example, such single locking membercould be incorporated into a one-way, locking hinge (not shown) operableto couple the retainer 18 to the body 14.

Depending upon the embodiment, the retainer 18 can be a door, panel,hook, U-shaped member or other capturing structure. The retainer 18 canbe moveably coupled to the body 14 through any suitable fastener orcoupler, including, but not limited to, a pivot member, pin, shaft,hinge, threaded engagement or tooth-based, interlocking structure. Thetimer 22 is operable to be adjusted, switched or otherwise changed froman inactive mode to an activate mode. In the inactive mode, the timer 22is not functional to track or indicate the passage of time. In theactive mode, the timer 22 is functional to track or otherwise indicatethe passage of time. For example, when the timer 22 is changed to theactive mode, the timer 22 starts a process of tracking the passage oftime, such as the passage of seconds, minutes, hours, days, weeks,months, years or any suitable fractions or portions of such timeperiods. In addition, the timer 22 generates a visual indication orvisual output representing such passage of time. For example, the timer22 can display, point to, or otherwise indicate “Hour 1,” “Hour 2,” Hour3,” “Day 1,” “Day 2,” “Day 3” and the like. In an embodiment, the timer22 generates an active indicator (e.g., a green light) indicating thatthe timer 22 is in the active mode. In an embodiment, the timer 22 alsogenerates an expiration indicator (e.g., a red light, a pulsating orflashing red light or an audible alert) indicating an expiration of theapplicable usage period of the medical article connected to the timer22.

In an embodiment, the timer 22 tracks and indicates the passage of timebased on a fluid or liquid diffusion process, as described below. Inanother embodiment, the timer 22 includes an electrical circuit orelectronic component, together with a battery or solar-based powersource. In such embodiment, the timer 22 electronically tracks andindicates the passage of time. For example, such timer 22 can generate adigital display of numerals, images or text corresponding to timepassage.

In an embodiment, the triggering element 26 is a structural portion ofthe retainer 18. In another embodiment, the triggering element 26 is astructural portion of the body 14. In yet another embodiment, thetriggering element 26 includes a structural portion of the retainer 18and a structural portion of the body 14. It should be appreciated thatin other embodiments, the triggering element 26 can include a ram, aplunger, a gear, an electrical conductor, an electrical switch oranother suitable electronic, electromechanical or mechanical actuatoroperable to trigger both the locking of the medical timing device 10 andthe changing of the timer 22 to its active mode.

The one or more locking members 30, 34, in an embodiment, cooperate tochange the medical timing device 10 from an open or unlocked position 46(FIG. 1) to a closed or locked position 50 (FIG. 2). In the lockedposition 50, the retainer 18 is irreversibly secured or locked to thebody 14. In an embodiment, locking member 30 includes a plurality ofsemi-rigid, flexible teeth, and locking member 34 includes a toothengager. For example, locking members 30, 34 can incorporate thestructure of a self-locking tie. Once the locking members 30, 34 aremoved together and engaged, the teeth and tooth engager prevent orinhibit the separation of the locking members 30, 34 without damaging ordestroying the locking members 30, 34.

The body 14 defines at least part of an article-receiving recess 38(e.g., a space or cavity) configured to at least partially receive anarticle portion 42 of a medical article. In the example shown, thearticle portion 42 is a tubular portion of a catheter. In operation, theuser opens the retainer 18 and inserts the article portion 42 into thearticle-receiving recess 38. Next, the user applies a single action 54(e.g., a hand closing force) to the retainer 18. Depending upon theembodiment, the single action 54 can be a downward, upward, sideward,rotary or other force. In the example shown, the single action 54 is adownward force. In response to the single action 54, the triggeringelement 26 causes the following outcomes or events to occur withoutrequiring any further action from the user: (a) the medical timingdevice 10 changes form the unlocked position 46 (FIG. 1) to the lockedposition 50 (FIG. 2), wherein the retainer 18 becomes locked with thebody 14, causing the medical timing device 10 to be locked onto thearticle portion 42; and (b) the timer 22 changes from its inactive modeto its active mode.

Depending upon the embodiment, such outcomes (e.g., locking and timeractivation) can occur simultaneously in response to the single action54, or such outcomes can occur sequentially in response to the singleaction 54. For example, the locking can occur a fraction of a secondbefore the timer activation, or the timer activation can occur afraction of a second before the locking.

In an embodiment illustrated in FIGS. 1-2, the medical timing device 10is incorporated into or otherwise attached to a medical device 58 which,in this example, is a catheter securement device 62. The cathetersecurement device 62 includes: (a) the medical timing device 10; and (b)a body support or base 66 coupled to the bottom body surface 70. Thebase 66, in an embodiment, is pivotally coupled to the body 14. The base66 also has a tissue interface 74 configured to be attached to the skintissue 78 of the patient. In an embodiment, the bottom body surface 70is detachably secured to the base 66 through use of a suitablenon-permanent adhesive. Likewise, the tissue interface 74 includes apeel-away layer that, when removed, exposes an adhesive layer on thetissue interface 74.

In use, an assembler adheres the body 14 to the base 66. Next, the user(e.g., clinician) adheres the base 66 to the skin tissue 78, such as theskin of the patient's thigh 80 (FIG. 10). Next, the user inserts thearticle portion 42 into the medical timing device 10 and applies asingle action 54, causing the timer 22 to activate and the medicaltiming device 10 to lock onto the article portion 42. If the patientmoves his/he legs slightly during treatment, the body 14 pivots relativeto the base 66 to relieve stress and forces that would otherwise urgethe catheter securement device 62 to separate from the skin tissue 78.

In an embodiment illustrated in FIGS. 3-31, the catheter securementdevice 82 is configured to be locked onto a three-way Foley urinarycatheter 86. The urinary catheter 86 is configured to be insertedthrough the patient's urethra until the distal end 84 (FIG. 11) reachesthe patient's bladder. Referring to FIGS. 6 and 11, in the exampleshown, the urinary catheter 86 includes: (a) a urine drainage channel orlumen (not shown) extending from the proximal urinary drainage branch 90to the distal end 84 of the urinary catheter 86, wherein the urinedrainage lumen is fluidly connected to distal opening 88 for fluidlycommunicating with the urine contents of the patient's bladder; (b) aninflation channel or lumen (not shown) extending form the proximalinflation branch 94 to the distal end 84 of the urinary catheter 86,wherein the inflation lumen is fluidly connected to a balloon orinflatable portion 96 of the urinary catheter 86; (c) an irrigationchannel or lumen (not shown) extending from the proximal irrigationbranch 98 to the to the distal end 84 of the urinary catheter 86,wherein the irrigation lumen is configured to be fluidly connected to asource of pressurized fluid or liquid for purposes of irrigating theurinary catheter 86 or delivering solutions through distal opening 88 tothe patient's bladder; and (d) a main tube 100 extending from thebranches 90, 94, 98 to the distal end 84 of the urinary catheter 86.

As shown in FIG. 11, the proximal end 102 of urinary catheter 86 has aY-shape or W-shape. It should be appreciated, however, that other typesand shapes of urinary catheters can be used with the catheter securementdevice 62. For example, the catheter securement device 62 can be used tosecure and time-track two-way urinary catheters having only two proximalbranches instead of three.

Referring to FIG. 15, in an embodiment, the catheter securement device82 includes: (a) a body 106; (b) a retainer 110 pivotally coupled to thebody 106; (c) a timer 114 supported by or coupled to the body 106; (d) atriggering element 118 (FIG. 6) incorporated into retainer 110; (e)retainer locking member 122 (FIG. 17) incorporated into retainer 110;(f) body locking member 126 (FIG. 13) incorporated into body 106; (g) abody support or base 130 coupled to body 106; and (h) a security cover134 attachable to the retainer 110 so as to sandwich the timer 114between the security cover 134 and the retainer 110. As described below,the base 130 is configured to anchor the urinary catheter 86 to thepatient's skin tissue.

In this embodiment, the triggering element 118 of retainer 110 includesthe exterior retainer surface 112 (FIG. 6) of the retainer 110. Asdescribed below, by pushing or applying a single action 54 force to theexterior retainer surface 112, the user can change the cathetersecurement device 82 from an unlocked position 138 (FIGS. 6 and 13-14)to a locked position 144 (FIGS. 3-5, 7-10 and 12).

The retainer 110 defines a pivot opening 142 (FIG. 17) configured toreceive a pivot member 146 (FIG. 17) of body 106. The pivot member 146couples to the retainer 110 in a press-fit or snap-fit configuration,wherein the pivot member 146 radially compresses, then snaps into thepivot opening 142, and then radially expands. In the expanded form, theperimeter of the collar 150 (FIG. 24) is greater than the perimeter ofthe pivot opening 142, thereby pivotally securing the retainer 110 tothe body 106. As shown in FIG. 29, the pivot member 146 has a splitconfiguration including a plurality of fingers 148 separated by a slitor gap 149. Upon insertion into the pivot opening 142, the fingers 148flex toward each other, and after full insertion, the fingers 148 arepredisposed to flex away from each other.

Furthermore, the retainer 110 defines: (a) a main recess 154 (FIG. 23)configured to receive the timer perimeter 160 (FIG. 21) of the timer114; and (b) a pass-through opening or passage 164 (FIG. 23) configuredto receive the flexible fluid container 168 (FIG. 21) of the timer 114.As illustrated in FIGS. 22-23, the retainer locking member 122 includesa flexible arm 172 having a plurality of retainer teeth 176. Each tooth176 has a retainer slide surface 180 and a retainer lock surface 184. Asdescribed below, as the catheter securement device 82 is locked, the arm172 flexes or bends while the retainer slide surfaces 180 slide againstthe body locking member 126 (FIGS. 24-26). Eventually, the retainer locksurfaces 184 become seated on the body lock surfaces 188 (FIG. 26).

As shown in FIG. 22, the retainer lock surface 184 can be angled atleast partially downward because the flexible arm 172 is predisposed toextend along a slanted axis 186 (FIG. 22) that intersects withhorizontal axis 190 in a non-perpendicular fashion. During locking, theflexible arm 172 moves so as to extend along a different axis (notshown) that also intersects with the horizontal axis 190.

In an embodiment, the retainer 110 also defines a lock access passage192, as illustrated in FIGS. 22-23. Lock access passage 192 enables atechnician to access the arm 172 to flex it in the unlock direction 196(FIG. 23) to unlock the retainer 110 from the body 106. This enables thetechnician to remove the catheter securement device 82 from the catheter86 for refurbishment, repair or other purposes. In another embodiment,the retainer 110 has a solid surface (not shown) that covers the lockaccess passage 192 for supplemental security.

The retainer 110 includes a lock guide 200, as illustrated in FIG. 22,that controls and guides the pivoting motion of the retainer 110relative to the body 106. In the embodiment shown, the lock guide 200has an arc-shape defining a plurality of equally spaced-apart guideslots 204. As the retainer 110 is pivoted for locking, the lock guide200 slides against the opposing body guide walls 208, 212 (FIG. 24). Inan embodiment, one or both of the body guide walls 208, 212 defines oneor more ridges or teeth configured to at least partially fit into theguide slots 204 of the retainer 110. Such arrangement can provideadditional locking security when the catheter securement device 82 islocked.

In an embodiment illustrated in FIG. 17, the retainer 110 includes aretainer mode controller 124, and the body 106 includes a body modecontroller 128. In this embodiment, when assembling the cathetersecurement device 62, the assembler positions the retainer 110 in theopen or unlocked position 138, as illustrated in FIG. 17. The retainermode controller 124 cooperates with the body mode controller 128 tocontrol the inactive and active modes of the catheter securement device62. In the example shown, the retainer mode controller 124 includes amember or retainer portion that interferes with the body mode controller128 which, in this example, is a finger, projection or detent 129extending upward from the body 106. This physical interference helps tomaintain the catheter securement device 62 in the inactive mode and openposition 138 while it is packaged, transported and inventoried forfuture use. This reduces the likelihood of an inadvertent orunintentional early activation of the catheter securement device 62.

When a user is ready to deploy the catheter securement device 62, theuser applies the single action 54 (e.g., a hand force) so as to overcomethe counteractive force of the body mode controller 128. For example,the detent 129 eventually fails, cracks or otherwise breaks to enablethe retainer mode controller 124 to continue moving, which enables theuser to fully lock the catheter securement device 62 in the closed orlocked position 144.

As illustrated in FIG. 23, the retainer 110: (a) defines a plurality ofsecurity openings or security slots 216; (b) includes security lips 224(FIG. 9) configured to receive and hold (or hook onto) the cover edges228 (FIG. 18) of security cover 134; and (c) defines L-shaped insertionguide slots 232 (FIG. 23) configured to receive the cover inserts 236(FIG. 20) of the security cover 134. The security slots 216 areconfigured to receive or mate with the security projections or securitytabs 220 (FIG. 20) of the security cover 134. In an alternativeembodiment (not shown) the security slots 216 are configured to lockwith the security projections or security tabs 220 of the security cover134. In an embodiment, the security cover 134 is a rigid or semi-rigidpanel that is partially or fully transparent, translucent or otherwisesee-through to enable the user to see the visual output of the timer114, as described below.

In an embodiment illustrated in FIG. 21, the timer 114 includes a timerbody 240 and the flexible fluid container 168 connected to the bottomside 242 of the timer body 240. In an embodiment, the timer body 240 isflexible or semi-rigid and includes a stack of substrates or layers of asuitable wicking material or porous material. Each such layer has aliquid absorption characteristic. The fluid container 168 is flexible ordeformable such as a pouch or bag, and the fluid container 168 includesa container bottom 246. The fluid container 168 is configured to hold,retain or contain a colored liquid, such as ink, paint or anothersuitable liquid having a dye, such as a red or blue dye. The timer 141includes a membrane or seal (not shown) located opposite of thecontainer bottom 246. When a force is applied to the liquid-filled fluidcontainer 168, this causes deformation of the fluid container 168 andincreased pressure within fluid container 168. When the pressure reachesa threshold level, the seal ruptures, enabling the liquid to traveltoward the stack of layers. The layers gradually absorb the liquidthrough diffusion. The rate of diffusion, which can depend upon theviscosity of the liquid and other factors, is associated with a clockfunction or time-tracking function. This non-electronic time-trackingfunction has the advantage of dependability independent of electricalpower. Therefore, this reduces the risk of time-tracking failures causedby bad batteries, power outages or failed electronic components.

As shown in FIGS. 9 and 12, the top side 250 of the timer 114 displays,indicates or otherwise includes: (a) a window or display area 254; (b) aline or series of time period markers 258 (e.g., vertical bars andcorresponding “1, 2, 3, 4, 5, 6, 7”) positioned in association with eachone of the time period markers 258; and (c) time-indicative symbols ortime text 262 (e.g., “7 Days”).

In operation, once the timer 114 is changed to the active mode, thetimer's diffusion process and time-tracking process begins. As thediffusion progresses, the display area 254 will change in color, shade,darkness or visible contrast, starting at the left end 266 andproceeding toward the right end 270. This visible change will graduallyenlarge in the time direction 274, gradually passing past the timeperiod markers 258 in sequence. In an embodiment, this gradualenlargement occurs like that of the rising volume of colored liquid in athermometer. In this example, when the visible change reaches the 7-Daysmarker 274 (e.g., the downward pointing triangle in FIG. 9), the urinarycatheter 86 has been in-use for its designated usage period. The usercan therefore easily recognize the need to replace the urinary catheter86. For example, when the timer 114 is in inactive mode, the displayarea 254 can be white, gray or black. When the timer 115 is in theactive mode and the designated usage period has expired, the displayarea 254 will have changed from its original non-colored appearance(e.g., white, gray or black) to a solid red color.

As illustrated in FIG. 15, in an embodiment, the body 106 includes anupper body portion 278 and a lower body portion 282. As described below,the upper body portion 278 (while locked with the retainer 110) isconfigured to be detached from the lower body portion 282. Similarly, asdescribed below, the lower body portion 282 is detachable from the base130. This enables the base 130 to be replaced if it becomes soiledbefore the expiration of the designated usage period of the urinarycatheter 86. Depending upon the circumstances, such soiling can includeurine, fecal material, blood, perspiration or other bodily fluids. Sincethe upper body portion 278 (and timer 114) remain locked to the urinarycatheter 86 during the replacement of the lower body portion 282, theuser is unable to wrongfully replace the timer 114 after the expirationof the usage period.

Referring to FIGS. 24-27, in an embodiment, the upper body portion 278defines at least part of an article-receiving space 286 (e.g., a cavityor recess) which includes: (a) a first passageway or channel 290configured to receive a portion of the proximal urinary drainage branch90; (b) a second passageway or channel 294 configured to receive aportion of the proximal inflation branch 94; (c) third passageway orchannel 298 configured to receive a portion of the proximal irrigationbranch 98; and (d) a fourth passageway or channel 302 configured toreceive a portion of the main tube 100.

Referring to FIGS. 24-26, the upper body portion 278 also includes: (a)a compressor 306 configured to apply a compression force to thecontainer bottom 246 (FIG. 21); (b) the body locking member 126; (c) thepivot member 146; and (d) the security lips 224, including side securitylips 310, 314 configured to be inserted into the side coupling orsecurity slots 319, 320 (FIG. 22), respectively, of retainer 110.

The compressor 306 has a ramp-shaped, upwardly sloped, or upwardlyinclined surface 318. The ramp or inclined surface 318 has a variableheight that gradually increase in height, transitioning from a firstlevel 322 (FIG. 24) to a second level 326 (FIG. 24), higher than thefirst level 322. When the retainer 110 is pivotally fastened to thepivot member 146, the pivot member 146 holds the retainer 110 at adesignated or fixed distance from the upper body portion 278. As theretainer 110 is pivoted in the closing or locking direction 330 (FIG.6), the inclined surface 318 applies a force to the container bottom246. As the pivoting progresses, this force gradually increases causedby the increasing height of the inclined surface 318. Consequently, theinclined surface 318 squeezes the flexible fluid container 168. Thisforce and squeezing action causes the internal seal (not shown) of thetimer 114 to rupture or break which, in turn, changes the timer 114 fromthe inactive mode to the active mode, as described above.

The body locking member 126 includes a plurality of tooth engagers 334.Each tooth engager 334 has a body slide surface 338 and a body lockingsurface 188 (FIG. 26). The body slide surfaces 338 are configured toslideably engage the retainer slide surfaces 180 while the retainer ispivoted in the locking direction 330. In this process, the flexible arm172 (FIG. 23) flexes away from the body slide surfaces 338 while, at thesame time, the flexible arm 172 applies an inward force, urging the bodyslide surfaces 338 toward the body slide surfaces 338. When the retainer110 is fully closed or locked in the locked position 144, the retainerslide surfaces 180 engage the recess walls 346, and the body lockingsurfaces 188 mate or otherwise physically engage the retainer lockingsurfaces 184 (FIG. 23). At this point, the body locking surfaces 188prevent the flexible arm 172 from becoming disengaged from the upperbody portion 278. In an embodiment, this process irreversibly orpermanently locks the retainer 110 to the body 106. Therefore, thislocked position 144, in an embodiment, prevents users from removing thecatheter securement device 62 from the urinary catheter 86, whetherbased on wrongful or erroneous intent. This provides tamper-resistant ortamper-proof protection for the time-tracking function of the cathetersecurement device 82.

In addition, as illustrated in FIGS. 27-28, the upper body portion 278of the catheter securement device 82 defines: (a) a first peripheralpassage 440 configured to receive, in snap-fit or press-fitconfiguration, a coupling riser or coupling post 442 of the lower bodyportion 282; (b) a second peripheral passage 446 having an arc shapeconfigured to receive an arc-shaped support 448 of the lower bodyportion 282; (c) a third peripheral passage 450 configured to receive,in snap-fit or press-fit configuration, a coupling riser or couplingpost 452 of the lower body portion 282; and (d) a fourth peripheralpassage 456 configured to receive, in snap-fit or press-fitconfiguration, a coupling riser or coupling post 458 of the lower bodyportion 282.

The post 442, support 448 and posts 452, 458 are configured to providesupport to the upper body portion 278. Furthermore, one or more of theseposts 442, 452, 458 functions to enable the upper body portion 278 to bedetachably or removably coupled to the lower body portion 282. Thisenables a user to replace a soiled base 130 while keeping the retainer110 and upper body portion 278 locked to the urinary catheter 86.

As illustrated in FIGS. 28-31, in an embodiment, the base 130 includes:(a) a rotary mount or pivot mount 460 having: (i) a neck 462 configuredto be inserted through the mount passage 464 that passes through thebottom surface 466 of the lower body portion 282; (ii) a head 468connected to the neck 462, wherein the head 468 has a head perimeter 470defining a plurality of head slots 472; and (iii) a mount support 473that is moveably, rotatable or pivotally coupled to the neck 462; and(b) a tissue interface 474 configured to physically interface with, andengage the tissue (e.g., skin) of the patient.

The mount passage 464 is defined by a perimeter wall 476 which furtherdefines a plurality of tabs, fingers or mount projections 478. To couplethe lower body portion 282 to the mount 460, the assembler aligns themount projections 478 with the head slots 472, then pushes the head 468through the mount passage 464, then rotates the head 468 relative to thelower body portion 282, and then releases. In an embodiment, thisresults in a press-fit or friction fit connection that inhibits theunintentional realignment of the mount projections 478 with the headslots 472. Once the head 468 is seated within the lower body portion282, the mount support 473 is configured to rotate or pivot relative tothe lower body portion 282. Depending upon the embodiment, the mountsupport 473 can be rigid, semi-rigid or flexible.

As illustrated in FIG. 28, the tissue interface 474, in an embodiment,includes: (a) a compliant or compressible body 480 configured to flex ordeform to conform to the shape of the patient's tissue; (b) a topsurface 482 having a top adhesive (e.g., suitable cement or glue)configured to adhere the compressible body 480 to the mount support 473;and (c) a bottom surface 484 (FIG. 16) having a bottom adhesive and anadhesive cover (not shown) overlying the bottom adhesive.

In an embodiment, the compressible body 480 includes a flexible foammaterial that is water proof or water resistant. In an embodiment, theadhesive cover is a wax-based substrate or layer configured to preservethe wetness and adhesion characteristics of the bottom adhesive. Toadhere the tissue interface 474 to the tissue of a patient, the userpeels away the adhesive cover, positions the bottom surface 484 on thetissue, and applies pressure. In doing so, the user attaches the entirecatheter securement device 62 to the patient's tissue which, in turn,anchors the urinary catheter 86 to the patient.

Periodically, the indwelling urinary catheter 86 will be subject toforces. These forces can be caused by movement of the patient's legs ortorso, the patient grasping the urinary catheter 86, or users (e.g.,clinicians) repositioning the indwelling urinary catheter 86 for medicaltreatment purposes. These forces are first applied to the body 106. Inresponse, the mount support 473 rotates or pivots relative to the body106. This movement relieves stress so as to reduce binding, kinking orbending of the urinary catheter 86. This relief also avoids or decreasesdiscomfort on the patient's tissue that would otherwise result from suchforces.

In an embodiment not shown, the catheter securement device 62 is mountedor incorporated into a patient harness or patient strap, such as thestrap 486 illustrated in FIG. 33. In such embodiment, the base 130excludes the tissue interface 474 because the strap 486 includes thetissue interface. Depending upon the embodiment, the base 130 canexclude the mount support 473 and be directly adhered, bonded orotherwise coupled to the strap 486.

In another embodiment illustrated in FIGS. 32-38, the cathetersecurement device 488 is configured to be adhered to skin tissue 490 ofa patient 493 or to the strap 486 (FIG. 33). The strap 486 is configuredto be removably attached to a patient's leg, arm or other body part. Inthe example shown in FIG. 34, the strap 486 is harnessed to the upperleg or thigh 487 of the patient 493.

Referring to FIG. 39, in an embodiment, the catheter securement device488 includes: (a) base 491 having an adhesive configured to adhere thebase 491 to the skin tissue 490 or strap 486; (b) a timer 492 adhered,bonded or otherwise connected to the base 491; (c) a body 494 adhered,bonded or otherwise connected to the timer 492; and (d) a retainer 495hinged to (and moveably coupled to) the body 494 through hinge 497 (FIG.40). The base 491 includes a plurality of layers, including a foam layer496 and a peel-away layer 498 to preserve the unapplied adhesive. Thetimer 492 includes a lower layer 500, an upper layer 502 (e.g., a top),a plurality of absorptive layers (not shown) between the layers 500,502, an activator, button or activation member 504, and a displayportion 506.

In an embodiment, timer 492 has the same diffusion-based, time-trackingfunction as timer 114 described above. As shown in FIG. 35, the body 494defines: (a) a first article-receiving space 512 configured to receive afirst portion of a catheter branch 514 of urinary catheter 515; (b) asecond article-receiving space 516 configured to receive a first portionof a catheter branch 518 of urinary catheter 515; and (c) a tooth locker520 configured to be interlocked with tooth 528 of the retainer 495.

The retainer 495: (a) defines a first article-receiving space 524configured to receive a second portion of the catheter branch 514; (b) asecond article-receiving space 526 configured to receive a secondportion of the catheter branch 518; and (c) a tooth 528 configured to beinserted into the tooth locker 520. The tooth 528 is predisposed toexert a biasing force on the tooth locker 520 to urge the projection 530into irreversible or permanent, locking engagement with the tooth locker520.

In operation, the user inserts the branches 514, 518 into the cathetersecurement device 488 when the catheter securement device 488 is in theunlocked position 532 (FIGS. 39-41). Next, the user applies a singleaction 54 (e.g., a downward force) to the retainer 495. As a result ofthe single action 54: (a) the tooth 528 travels through the tooth locker520, and the tooth end 534 (FIGS. 41-42) makes contact with, and appliesa force to, the activation member 504; and (b) the tooth 528 becomelocked together with the tooth locker 520, thereby causing continuousapplication of such force on the activation member 504. In anembodiment, this force ruptures an internal seal or membrane of thetimer 492, causing the timer 492 to change to the active mode forindicating the passage of time. In another embodiment, this force causesthe liquid in the timer 492 to diffuse throughout the timer 492, causingthe timer 492 to change to the active mode for indicating the passage oftime. Due to this single action 54, the catheter securement device 488is changed to the locked position 533 (FIGS. 36 and 42).

As illustrated in FIGS. 36 and 38, the display portion 506 displays orindicates a continuous indicator (e.g., color contrast), graduallyexpanding from starting period marker 536 to ending period marker 538.In this example, ending period marker 538 indicates a seven day usageperiod, the designated usage period for the urinary catheter 515. At dayone, the timer 492 displays an initial color contrast level 539 (FIG.36), and at day seven, the timer 492 displays the ending color contrastlevel 540 (FIG. 38) associated with the expiration of the designatedusage period.

In another embodiment illustrated in FIGS. 43-46, the catheter insertiondressing or catheter insertion cover 544 is configured to cover the site546 at which a venous catheter 548 is inserted through a hole in theskin 550 of a patient 553. The venous catheter 548 can be a centralvenous catheter including intravenous (IV) tubing for continuous accessto the central vein of the patient for administering fluids andmedicines over time. In this embodiment, the catheter insertion cover544 includes a flexible body 551. The body 541 defines a transparent orsee-through window 552 configured to overlay the hole in the skin 550.The body 551 also defines a cut-out or slot 554 configured to receive aconnector 557 of the venous catheter 548. The top 559 reveals ordisplays a display portion 556 having period markers 558. The bottom 560(FIG. 44) has an adhesive layer covered by a peel-away layer.

In an embodiment, the catheter insertion cover 544 includes: (a) abutton or time activation member 562; and (b) a timer having the samestructure, functionality and elements as the timer 492 described above.To deploy the catheter insertion cover 544, the user prepares the skinsite 546 and then inserts the venous catheter 548 into the patient'scentral vein. Next, the user removes the peel-away layer from the bottom560 of the catheter insertion cover 544. Next, the user positions thebottom 560 onto the skin 550 so that the window 552 covers the site 546,and the connector 557 is located within the slot 554. Finally, the usercan apply a single action 54, such as a palm or finger pressing force onthe top 559. This force, including a sub-force applied to the timeactivation member 562, causes the timer to enter into the active mode,and it also causes the catheter insertion cover 544 to be adhered to thepatient. In an embodiment, this force ruptures in internal seal ormembrane of the timer, causing the timer to change to the active modefor indicating the passage of time. In another embodiment, this forcecauses the liquid in the timer to diffuse throughout the timer, causingthe timer to change to the active mode for indicating the passage oftime.

As illustrated in FIGS. 43 and 46, the display portion 556 displays orindicates a continuous indicator (e.g., color contrast), graduallyexpanding from starting period marker 564 to ending period marker 566.In this example, ending period marker 566 indicates a seven day usageperiod, the designated usage period for the venous catheter 548. At dayone, the timer displays an initial color contrast level 568 (FIG. 43),and at day seven, the timer displays the ending color contrast level 570(FIG. 46) associated with the expiration of the designated usage period.

In another embodiment illustrated in FIGS. 47-50, the medical timingdevice 572 is configured to be locked to any medical tube 574 forpurposes of tracking and indicating the in-use time of the medical tube574 or the medical equipment attached to the medical tube 574. Themedical tube 574 can include, without limitation, an IV bag tube, afeeding bag tube or any other tube used for medical purposes. In theexample illustrated, the medical timing device 572 is used to track thein-use time of IV tube 574 fluidly connected to an IV bag 576.

In this embodiment, the medical timing device 572, having a clam shellconfiguration, includes: (a) a first portion 578 defining a firsttubular channel 580 configured to receive a first portion of the medicaltube 574; (b) a second portion 582 moveably coupled to the first portion578 through a hinge 584, wherein the second portion 582 defines a secondtubular channel 586 configured to receive a second portion of themedical tube 574; (c) a button or time activation member 588 coupled tothe first portion 578; (d) a ram or driver 590 coupled to the secondportion 582 and configured to make contact with, and apply a force to, atimer activation portion 592 (FIG. 50), such as an internal seal ormembrane of the timer described below; (e) a plurality of frictional,traction or gripping members 594 configured to frictionally oradhesively engage the medical tube 574 when the medical timing device572 is clamped onto the medical tube 574 in the locked position 596(FIGS. 47-48); (f) a plurality of one-way fasteners or locking members598 coupled to the first portion 578 which are configured to beirreversibly secured to or locked with the second portion 582 when thelocking members 598 are inserted through the lock openings 600 definedby the second portion 582; (g) a display portion 602 coupled to thefirst portion 578, wherein the display portion 602 displays a series ofperiod markers 604; and (h) a timer having the same structure,functionality and elements as the timer 492 described above.

To deploy the medical timing device 572, the user separates the portions578, 582 to achieve the unlocked position 606 illustrated in FIG. 49.Next, the user inserts the medical tube 578 into the channels 580, 586.Next, the user closes the medical timing device 572 to reach the lockedposition 596. In the locked position 596, the gripping members 594engage the medical tube 574 (FIG. 47) to inhibit the medical timingdevice 572 from undesirably sliding on the medical tube 574. Also, inthe locked position 596, the locking members 598 are locked togetherwith the structure of the second portion 582 that defines the lockopenings 600.

Next, the use presses the actuator or time activation member 588, whichcauses the driver 590 to apply a force to the timer activation portion592 (FIG. 50). This force causes the timer to enter into the activemode. In an embodiment, this force ruptures in internal seal or membraneof the timer, causing the timer to change to the active mode forindicating the passage of time. In another embodiment, this force causesthe liquid in the timer to diffuse throughout the timer, causing thetimer to change to the active mode for indicating the passage of time.The display portion 602 displays or indicates a continuous indicator(e.g., color contrast), gradually expanding from starting period marker608 (indicating day one) to the ending period marker 610 (indicating dayfour). In this example, ending period marker 610 indicates a four dayusage period, the designated usage period for the medical tube 574 orits permanently attached equipment (e.g., IV bag 756).

In another embodiment illustrated in FIGS. 51-55, the medical timingdevice 612 is configured to be locked to a corrugated ventilation tube614 which, in turn, is fluidly connected to an endotracheal tube 616.The endotracheal tube 616 is configured to be inserted into the tracheaof a patient 617, and ventilation tube 614 delivers air through theendotracheal tube 616 based on air supplied by a ventilator or breathingmachine. In the embodiment illustrated, the endotracheal tube 616 has acorrugated exterior surface 618, as illustrated in FIG. 52. Thecorrugated exterior surface 618 has a series of spaced-apart ridges or aseries of peaks 620 and valleys 622 configured to add some degree ofstiffness to the ventilation tube 614 while enabling the ventilationtube 614 to be flexed or bent without kinking.

As illustrated in FIGS. 53-54, in this embodiment, the medical timingdevice 612 includes: (a) a first portion 624 defining a first tubularchannel 626 configured to receive a first portion of the ventilationtube 614; (b) a second portion 628 moveably coupled to the first portion624 through a hinge 630, wherein the second portion 628 defines a secondtubular channel 632 configured to receive a second portion of theventilation tube 614; (c) a tooth 634 coupled to the first portion 624,wherein the tooth 634 has a ram or driver 636 configured to make contactwith, and apply a force to, a timer activation portion 638 (FIG. 54),such as an internal seal or membrane of the timer described below; (d) alocking member 640 of the second portion 628, wherein the locking member640 defines a lock opening 642 configured to receive the tooth end 644;(e) a display portion 646 coupled to the first portion 624, wherein thedisplay portion 646 displays a series of period markers 648; and (f) atimer having the same structure, functionality and elements as the timer492 described above.

Referring to FIG. 53, in an embodiment, each of the portions 624, 628has an interior surface 649. The interior surface 649 defines aplurality of peaks 651 and valleys 653. When the user inserts theventilation tube 614 into the medical timing device 612, at least onepeak 651 fits within one of the valleys 622 (FIG. 52), and at least onevalley 653 receives one of the peaks 620 (FIG. 52). This matingengagement between the corrugated exterior surface 618 and the medicaltiming device 612 inhibits the undesired sliding or movement of themedical timing device 612 along the longitudinal axis of the ventilationtube 614.

To deploy the medical timing device 612, the user separates the portions624, 628 to achieve the unlocked position 650 illustrated in FIG. 53.Next, the user inserts the ventilation tube 614 into the passageway 652(FIG. 54) defined collectively by the united channels 626, 632. Next,the user closes the medical timing device 612 to reach the lockedposition 654 (FIGS. 51-52 and 54-55). In the locked position 654, theinterior surface 649 is mated with the corrugated exterior surface 618as described above. Next, the user applies a single action 54, such as aclosing force moving the portions 624, 628 together. In response to suchsingle action 54, multiple outcomes occur. One of the outcomes is thatthe hook-shaped portion 656 of the tooth end 644 becomes locked togetherwith the locking member 640. This locks the medical timing device 612onto the ventilation tube 614. Another one of the outcomes is that thetooth end 644 drives into the timer activation portion 638, applying aforce to the timer activation portion 638. This force causes the timerto enter into the active mode. In an embodiment, this force ruptures ininternal seal or membrane of the timer, causing the timer to change tothe active mode for indicating the passage of time. In anotherembodiment, this force causes the liquid in the timer to diffusethroughout the timer, causing the timer to change to the active mode forindicating the passage of time.

In the active mode, the display portion 646 displays or indicates acontinuous indicator (e.g., color contrast), gradually expanding fromstarting period marker 658 (indicating day one) to the ending periodmarker 660 (indicating day seven). In this example, ending period marker660 indicates a seven day usage period, the designated usage period forthe ventilation tube 614 or its permanently attached equipment (e.g.,endotracheal tube 616).

In certain embodiments described above, such as medical device 58,catheter securement devices 62, 82, catheter securement device 488 andmedical timing device 612, multiple outcomes (e.g., locking and timeractivation) result from a single action 54. This can provide asignificant advantage for users. For example, in the midst of highhospital time pressures, this single step or single action enables anurse or other clinician to deploy either such device with greatersecurity, speed, ease of use, simplicity and certainty than conventionalmethods for tracking the in-use time of medical articles.

In other embodiments, the catheter insertion cover 544, medical timingdevice 572 or alternative embodiments of the medical device 58, cathetersecurement devices 62, 82, catheter securement device 488, or medicaltiming device 612 can be configured and operable to perform the lockingand timer activation outcomes in response to multiple user actions orsteps. In such embodiments, such cover and devices provide advantages ofgreater security, speed, ease of use, simplicity and certainty thanconventional methods for tracking the in-use time of medical articles.

In the examples described above and illustrated in the figures, certainusage periods are described, such as a seven or four day usage period.These periods are only examples. It should be appreciated that themedical community or healthcare industry can convey any suitablestandards to establish any designated usage periods for various medicalarticles.

The locking functionality of the medical device 58, catheter securementdevices 62, 82, catheter securement device 488, medical timing device572 and medical timing device 612 is described above, at times, as beingirreversible or permanent. It should be understood that, in someembodiments, this locking functionality enables a technician or user tounlock or open either such device using a suitable tool. Furthermore, itshould be understood that, in some embodiments, this lockingfunctionality enables a technician or user to unlock or open either suchdevice by cracking, breaking or damaging such device. In addition, itshould be understood that, in some embodiments, this lockingfunctionality enables a technician or user to unlock or open either suchdevice by exerting substantial force, effort or time, such as more thanhand force or more than ten seconds of effort.

In an embodiment, the medical device 58, catheter securement device 82,catheter securement device 488, medical timing device 572 and medicaltiming device 612 are each constructed of a suitable polymer, such as ahard or rigid plastic, a semi-rigid plastic, a synthetic or naturalrubber, a foam, a single or stack of polymeric substrates or layers or asuitable metal or combination of the foregoing. Furthermore, in anembodiment, such materials include an antimicrobial additive,antimicrobial characteristic, antibacterial additive or antibacterialcharacteristic to deter the growth or onset of harmful microbialorganisms and bacteria.

Additional embodiments include any one of the embodiments describedabove, where one or more of its components, functionalities orstructures is interchanged with, replaced by or augmented by one or moreof the components, functionalities or structures of a differentembodiment described above.

It should be understood that various changes and modifications to theembodiments described herein will be apparent to those skilled in theart. Such changes and modifications can be made without departing fromthe spirit and scope of the present disclosure and without diminishingits intended advantages. It is therefore intended that such changes andmodifications be covered by the appended claims.

Although several embodiments of the disclosure have been disclosed inthe foregoing specification, it is understood by those skilled in theart that many modifications and other embodiments of the disclosure willcome to mind to which the disclosure pertains, having the benefit of theteaching presented in the foregoing description and associated drawings.It is thus understood that the disclosure is not limited to the specificembodiments disclosed herein above, and that many modifications andother embodiments are intended to be included within the scope of theappended claims. Moreover, although specific terms are employed herein,as well as in the claims which follow, they are used only in a genericand descriptive sense, and not for the purposes of limiting the presentdisclosure, nor the claims which follow.

The following is claimed:
 1. A medical dressing comprising: a flexiblebody comprising a top and a bottom; an adhesive coupled to the bottom,wherein the adhesive is configured to adhere the bottom to a skin site;and a window supported by the flexible body, wherein the windowcomprises a see-through surface configured to cover at least part of theskin site; a timer coupled to the flexible body, wherein the timercomprises: a fluid container positioned between the top and the bottomof the flexible body, wherein the fluid container is configured to holda liquid; and at least one absorptive layer supported by the flexiblebody; a time activation member supported by the flexible body; and adisplay portion supported by the flexible body, wherein the displayportion comprises a plurality of period markers, wherein, in response toa force applied to the time activation member: the fluid container isconfigured to unseal, causing the liquid to at least partially diffusethrough the at least one absorptive layer at a diffusion ratecorresponding to a time-tracking function; and the display portion isconfigured to indicate a passage of time based on the diffusion rate. 2.The medical dressing of claim 1, wherein: the skin site comprises avascular insertion site; the window is flexible; and the see-throughsurface is one of fully transparent, partially transparent, fullytranslucent, and partially translucent.
 3. The medical dressing of claim1, wherein: the liquid comprises a color; the display portion isconfigured to display the color along a path; and the path extends atleast partially around the window.
 4. The medical dressing of claim 1,wherein the fluid container comprises a seal configured to be rupturedin response to the force.
 5. The medical dressing of claim 1, wherein:the timer comprises a stack of absorptive layers, wherein the stackcomprises the at least one absorptive layer; and the stack is associatedwith a wicking characteristic.
 6. The medical dressing of claim 1,wherein the time activation member is a region of the top of theflexible body.
 7. The medical dressing of claim 1, wherein the displayportion is a region of the top of the flexible body, wherein the regionis one of fully transparent, partially transparent, fully translucent,partially translucent, and see-through.
 8. The medical dressing of claim1, wherein: the display portion defines a path comprising: a first endlocated adjacent to the time activation member; and a second end locatedopposite of the first end; the display portion comprises a plurality ofperiod markers between the first and second ends of the path; the periodmarkers are associated with a designated usage period; the periodmarkers comprise: (a) a starting period marker adjacent to the first endof the path; and (b) an ending period marker adjacent to the second endof the path.
 9. A medical dressing comprising: a body comprising a topand a bottom; a see-through surface supported by the body; and a timercoupled to the body, wherein the timer comprises a structure configuredto track a passage of time based on liquid diffusion.
 10. The medicaldressing of claim 9, wherein: the body comprises a flexible structurecomprised of one or more layers; and the medical dressing comprises anadhesive applied to the bottom, wherein the adhesive is configured toadhere the bottom to skin.
 11. The medical dressing of claim 9, wherein:the top of the body comprises an activation portion, wherein theactivation portion is configured to: (a) receive a force; and (b)transmit the force to the structure of the timer; and the top of thebody comprises a display portion, wherein the display portion isconfigured to indicate the passage of time tracked by the timer.
 12. Themedical dressing of claim 9, wherein: the structure of the timercomprises a fluid container and an absorptive element; the fluidcontainer is at least partially positioned between the top and thebottom of the body; the fluid container is configured to contain a fluidthat is configured to at least partially diffuse through the absorptiveelement.
 13. The medical dressing of claim 12, comprising: an activationmember configured to: (a) receive a force; and (b) unseal the fluidcontainer in response to the force, wherein the activation member is oneof: (i) a portion of the body, (ii) a portion of the top, and (iii) aportion of the timer; and a display portion configured to indicate thepassage of time, wherein the display portion is one of: (i) a portion ofthe body, (ii) a portion of the top, and (iii) a portion of the timer.14. The medical dressing of claim 13, wherein: the fluid comprises acolor; the display portion is configured to display the color along apath; and the path extends at least partially around the see-throughsurface.
 15. The medical dressing of claim 9, wherein: the see-throughsurface is flexible; the see-through surface is one of fullytransparent, partially transparent, fully translucent, and partiallytranslucent; and the body defines a slot configured to at leastpartially receive a portion of a medical catheter.
 16. A medicaldressing comprising: a body comprising: a top; a bottom configured to besecured to a skin site; a flexible structure comprised of one or morelayers; a see-through surface supported by the body, wherein thesee-through surface provides visibility to at least a portion of theskin site; and a timer coupled to the body, wherein the timer excludesan electrical power source; and a display portion supported by the body,wherein the display portion is configured to indicate a passage of timebased on a function of the timer.
 17. The medical dressing of claim 16,wherein the timer comprises a structure configured to track the passageof time based on liquid diffusion without being powered by a battery.18. The medical dressing of claim 17, wherein: the structure of thetimer comprises a fluid container and an absorptive element; and thefluid container is at least partially positioned between the top andbottom of the body; the fluid container is configured to contain a fluidthat is configured to at least partially diffuse through the absorptiveelement.
 19. The medical dressing of claim 18, comprising: an activationmember configured to: (a) receive a force; and (b) unseal the fluidcontainer in response to the force, wherein the activation member is oneof: (i) a portion of the body, (ii) a portion of the top, and (iii) aportion of the timer; and the display portion is one of: (i) a portionof the body, (ii) a portion of the top, and (iii) a portion of thetimer.
 20. The medical dressing of claim 19, wherein: the see-throughsurface is positioned within a perimeter; the display portion isconfigured to display an indication of the fluid extending along a path;and the path comprises a curved shape, extending at least partiallyaround the perimeter.